U.S. patent number 11,430,554 [Application Number 16/809,574] was granted by the patent office on 2022-08-30 for pharmacy stock supply tracking system.
This patent grant is currently assigned to GSL SOLUTIONS, INC.. The grantee listed for this patent is GSL Solutions, Inc.. Invention is credited to Shelton Louie.
United States Patent |
11,430,554 |
Louie |
August 30, 2022 |
Pharmacy stock supply tracking system
Abstract
An automated tracking system for a pharmacy that tracks unique
identifiers ("UI") with a stock supply of an item or items within a
supply container and that provides a security system for
determining a discrepancy associated with the stock supply. The UI
information automatically travels with the stock supply until it is
dispensed to a customer or patient, thereby allowing the system to
monitor and track supply for replenishment of the supply or
improper or potentially fraudulent transactions. If desired, the
improved security allows supply containers and individual supplies
within those containers to be stored in the same storage area
thereby maximizing available storage space while still improving
dispensing and filling accuracy and minimizing loss.
Inventors: |
Louie; Shelton (Vancouver,
WA) |
Applicant: |
Name |
City |
State |
Country |
Type |
GSL Solutions, Inc. |
Vanvouver |
WA |
US |
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Assignee: |
GSL SOLUTIONS, INC. (Vancouver,
WA)
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Family
ID: |
1000006528702 |
Appl.
No.: |
16/809,574 |
Filed: |
March 5, 2020 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20210043290 A1 |
Feb 11, 2021 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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15331863 |
Oct 22, 2016 |
11244747 |
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14885960 |
Oct 16, 2015 |
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16809574 |
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14727584 |
Jun 1, 2015 |
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16809574 |
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14082607 |
Nov 18, 2013 |
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13931012 |
Jun 2, 2015 |
9047992 |
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13282196 |
Nov 19, 2013 |
8584941 |
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13050308 |
Jul 9, 2013 |
8479988 |
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13027075 |
Jul 2, 2013 |
8474716 |
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13027075 |
Jul 2, 2013 |
8474716 |
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62064911 |
Oct 16, 2014 |
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61444062 |
Feb 17, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G16H
20/13 (20180101); G16H 20/10 (20180101); G06Q
10/087 (20130101); G06Q 10/083 (20130101); B65B
57/18 (20130101); B65B 57/10 (20130101) |
Current International
Class: |
G16H
20/10 (20180101); G16H 20/13 (20180101); G06Q
10/08 (20120101); B65B 57/10 (20060101); B65B
57/18 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0899677 |
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Mar 1999 |
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EP |
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1049042 |
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Nov 2000 |
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EP |
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WO-2006084310 |
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Aug 2006 |
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WO |
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WO-2008006203 |
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Jan 2008 |
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WO |
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WO-2013082392 |
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Jun 2013 |
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WO |
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Primary Examiner: Lam; Eliza A
Attorney, Agent or Firm: Morgan, Lewis & Bockius,
LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to and is a continuation-in-part
of U.S. patent application Ser. No. 14/082,607, filed on Nov. 18,
2013 which is a continuation-in-part of U.S. patent application
Ser. No. 13/282,196, filed Oct. 26, 2011, now U.S. Pat. No.
8,584,941, which is a continuation of U.S. patent application Ser.
No. 13/050,308, filed Mar. 17, 2011, now U.S. Pat. No. 8,479,988,
which claims the benefit of 61/444,062, filed Feb. 17, 2011, is a
continuation-in-part U.S. patent application Ser. No. 13/027,075,
filed Feb. 14, 2011, now U.S. Pat. No. 8,474,716. The entire
disclosure of these references is hereby incorporated by
reference.
This application also claims priority to and is a
continuation-in-part of Ser. No. 14/727,584, filed on Jun. 1, 2015,
which is a continuation-in-part of U.S. application Ser. No.
13/931,012, filed on Jun. 28, 2013, now U.S. Pat. No. 9,047,992,
issued on Jun. 2, 2015, which is a continuation of U.S. application
Ser. No. 13/027,075, filed on Feb. 14, 2011, now U.S. Pat. No.
8,474,716, issued on Jul. 2, 2013. The entire disclosure of these
references is hereby incorporated by reference.
This application also claims priority to and is a
continuation-in-part of U.S. patent application Ser. No.
15/331,863, filed Oct. 22, 2016, now U.S. Pat. No. 11,244,747,
which is a continuation-in-part of U.S. patent application Ser. No.
14/885,960, filed on Oct. 16, 2015, now abandoned, which claims
priority to U.S. provisional patent application Ser. No. 62/064,911
filed on Oct. 16, 2014. This entire disclosure of these references
is hereby incorporated by reference.
Claims
I claim:
1. A pharmacy system comprising: a computer system; a tag reader in
communication with the computer system and configured to wirelessly
detect a presence of respective tags; a database in communication
with the computer system and storing at least one unique identifier
associated with a stock supply of an item contained in a stock
container, the computer system configured to: detect, using the tag
reader, that a first machine readable tag associated with a patient
prescription container is within a proximate location of a second
machine readable tag associated with the stock container when a
portion of the stock supply of an item is dispensed from the stock
container to patient prescription container; and automatically
associating, based on the detecting, the at least one unique
identifier with the portion of the stock supply of the item placed
in the patient prescription container; and, a security system in
communication with the computer system having a security module
configured to detect a predetermined discrepancy associated with
the portion of the stock supply being dispensed from the stock
container.
2. The pharmacy system of claim 1, wherein the stock supply of an
item is a unit of use.
3. The pharmacy system of claim 1, wherein the stock supply of an
item contains a plurality of items and each of the plurality of
items is associated with a same common group.
4. The pharmacy system of claim 3, wherein the common group is a
patient, and the plurality of items are a plurality of medications
for that patient.
5. The pharmacy system of claim 3, wherein the common group is a
collection of items used to treat a particular medical
condition.
6. The pharmacy system of claim 5, wherein the particular medical
condition is selected from the group consisting of first aid
treatment, cardiac treatment, burn treatment, laceration treatment,
anesthesia treatment, and a predetermined medical procedure.
7. The pharmacy system of claim 1, further including: a worker
identification system in communication with the computer system for
individually identifying workers within the pharmacy; and, wherein
the security system is a storage area having a tag reader in
communication with the computer system thereby allowing the
computer to detect the identity of the worker accessing one of the
stock containers within the storage area.
8. The pharmacy system of claim 1, wherein the security system
comprises a cabinet for storing patient prescription containers and
stock containers including the stock container therein, the cabinet
comprising: a frame defining a storage area therein; an access
panel having an open position wherein the storage area is
accessible to a worker and a closed position wherein the storage
area is inaccessible to a worker; at least one transducer operably
secured to the cabinet operable by the computer system to alert a
worker as to the location of the patient prescription container
within the cabinet; and, a worker identification system in
communication with the computer system for limiting access to the
storage area to a specifically identified worker by selectively
activating the transducer based on the identity of the worker.
9. The pharmacy system of claim 1, wherein the security system
includes a cabinet for storing stock containers therein, the
cabinet having: a frame defining a storage area therein; an access
panel having an open position wherein the storage area is
accessible to a worker and a closed position wherein the storage
area is inaccessible to a worker; a lock in communication with the
computer system that is activated by the computer system based on
predetermined criteria; and, a worker identification system in
communication with the computer system for limiting access to the
storage area to a specifically identified worker by the computer
system selectively activating the lock on the access panel.
10. The pharmacy system of claim 9, wherein the worker
identification system is a machine readable tag operably secured to
the worker.
11. The pharmacy system of claim 10, wherein the machine readable
tag is selected from the group consisting of a Radio Frequency
Identification Tag and a biometric reader.
12. The pharmacy system of claim 11, further including a plurality
of access panels, each panel having a panel lock in communication
with the computer system, each panel lock independently activated
by the computer system based on predetermined criteria.
13. The pharmacy system of claim 12, wherein the predetermined
criteria provides that the lock to at least one of the access
panels is unlocked only for storing a stock container within the
storage area.
14. The pharmacy system of claim 9, wherein the computer system
maintains a perpetual log of a worker's identity and contents of
the stock container within the cabinet for said worker.
15. The pharmacy system of claim 12, wherein the computer system
automatically assigns possession of the stock container upon that
worker removing the stock container order from the storage
area.
16. The pharmacy system of claim 1, wherein the computer system
maintains a perpetual log of a unique identifier (UI) associated
with a stock container and associates that UI with a customer who
has been provided an item from the stock container.
17. The pharmacy system of claim 1, wherein the security system is
a status change module for automatically changing a status of items
within the system subject to a status change.
18. The pharmacy system of claim 1, wherein the security system is
an automatic real-time inventory module for generating real-time
inventory reporting of items received within the pharmacy.
19. The pharmacy system of claim 18, wherein the security system
includes providing notice to a worker that a quantity of an item
within a supply container has dropped below a predetermined
threshold and needs to be replenished.
20. The pharmacy system of claim 1, wherein the security system is
a receive module for providing real-time discrepancy monitoring and
notification of bulk supplies entered into the system as supply
containers by the computer system automatically comparing a
manifest of the supplies with tags associated with one or more
supply containers containing products from that manifest.
Description
BACKGROUND
Automated systems and methods for monitoring and tracking
prescription orders, pharmacy supply containers, filled
prescriptions and the like are known. Examples of these systems can
be found in U.S. Pat. No. 8,479,988 to Louie, et al., and U.S. Pat.
No. 7,747,477 to Louie et al., the disclosures of which are hereby
incorporated by reference.
Also, local retail pharmacies, healthcare facilities and the like
are increasingly relying on remote, "central fill" pharmacies to
fill prescription orders of customers and patients and ship the
filled prescriptions to the local retail pharmacy or healthcare
facility for dispensing to the customer or patient. An exemplar,
remote "central fill" pharmacy system is shown in U.S. Pat. No.
7,448,544 to Louie et al., the disclosure of which are hereby
incorporated by reference.
In addition, automated prescription filling machines are known and
in common use. These machines automatically count and dispense a
desired medication into a container and apply a label containing
customer identifying information. Some of these machines include
automated verification systems, such as measuring the weight of the
filled prescription and comparing it to a predetermined weight and
flagging an error if the detected weight differs from the
predetermined weight. These systems can also include automated
visual detection systems such as cameras or the like that can
physically count the number of pills dispensed and the appearance
of the pills and compare those detected values with predetermined
criteria and flag any discrepancies detected. Exemplar automated
filling system are shown in U.S. Pat. No. 8,275,481 to Rice et al.,
U.S. patent application Ser. No. 13/473,267 to Luciano, et al., and
U.S. patent application Ser. No. 13/325,782 to Rhoads, the
disclosures of which are hereby incorporated by reference. These
automated verification systems have proven themselves to be
accurate and reliable.
In general, a licensed pharmacy technician or pharmacist is
required to verify that a prescription for a customer has been
properly filled. This verification usually includes verifying that
the proper medication has been loaded into the correct locations
within an automated filling machine, and that the proper amount of
that medication has been placed in the container earmarked for the
customer/patient, and that the customers/patient's container is
properly labeled. Labeling includes identifying information about
the medication, quantity, how to take the medication contained
therein and the customer/patient it is intended for.
In cases where a prescription order is filled at a remote facility,
there may be several licensed pharmacy technicians and/or
pharmacists along the filling flow process that perform the same
verification steps for the same prescription and supply container
orders. While such redundant verification is certainly beneficial
in the rare case where verification along the flow process is
erroneous, it needlessly increases the workload of the pharmacy
technicians/pharmacists. Moreover, it requires more licensed
pharmacy technicians & pharmacists to be involved in the
filling and dispensing process than needed to accurately and
consistently dispense the correct medications to patients and
customers. Since the demand on licensed pharmacy technicians and
pharmacists is continuing to increase, these redundant verification
systems can compromise a pharmacy's ability to timely dispense
medications to patients and customers.
Moreover, most medical-related items and medications have Unique
Identifiers such as Unique Drug Identity ("UDI") information
associated with it including its lot number, expiration date,
pedigree code, National Drug Code ("NDC"), Drug Identification
Number ("DIN"), cost and pricing information, and the like. This
information is provided by the manufacturer of the medical items or
medication within the supply container. However, much of this
information, and even the fact the item or items have been removed
from the container, is lost for when the item is withdrawn from the
supply container.
Also, many medications have become increasingly expensive with
individual doses of certain medications costing as much as several
thousand dollars per dose. The costs to stock such medications have
become increasingly burdensome to some pharmacies, and they risk
losing their investment in cases where the stocked medication
expires before it can be dispensed. As a result, many pharmacies
will not stock certain medications, and instead order such
medication from the manufacturer as it receives an order for it by
customers. This ordering process can take several days before the
medication is available to be dispensed to a customer, thereby
delaying when a customer can start treatment.
Similarly, given the large number of workers involved in filling
and dispensing a prescription order, there is little tracking or
accountability of workers who have access to medications contained
in supply containers and/or individual filled prescriptions. This
lack of accountability can contribute to loss and theft of
medications by workers.
Also, should a particular medication be recalled by its
manufacturer or for another reason, the process of manually
locating unused supplies of the medication within a pharmacy or
awaiting customer pickup in a will call area is time consuming, and
this process can miss some medications from being timely
recalled.
Moreover, known pharmacy storage systems often require that supply
containers and individual filled prescriptions awaiting pickup be
stored in separate storage areas within a pharmacy, which often
already have limited space to accommodate two separate storage
areas.
SUMMARY
Thus, despite the known systems for filling prescription orders of
customers and patients and filling and loading supply containers
containing medications into automated filling machines, there
remains a need for a cost effective system that consistently and
accurately verifies supplies within supply containers within a
pharmacy without needlessly requiring multiple verifications from
different workers within the pharmacy.
Moreover, there remains a need for medical item unique identifiers
and medication UDI information of a supply to follow the filling
flow through a system to each individual items are dispensed to a
customer or patient.
In addition, there remains a need for the financial information of
a supply of medication to follow the filling flow through a system
to each individual filled prescription order of a customer such
that financial ownership of a particular customer's supply of
medication and that customer's payment for it can pass directly
between the manufacturer or a third party owner of the medication
and the customer without a dispensing pharmacy being held
financially responsible as an "owner" of the supply of medication
while under its control.
Also, there remains a need for an automatic fraud detection system
that monitors dispensing of medications by each worker compared to
a predetermined criteria and alerts management should a discrepancy
be detected.
In addition, there remains a need for a reliable and secure storage
device that allows supply containers and individual filled
prescription orders to both be stored therein while still allowing
controlled access and detailed tracking of these items.
The advantages and features of novelty characterizing aspects of
the invention are pointed out with particularity in the appended
claims. To gain an improved understanding of the advantages and
features of novelty, however, reference may be made to the
following descriptive matter and accompanying figures that describe
and illustrate various configurations and concepts related to the
invention.
FIGURE DESCRIPTIONS
The foregoing Summary and the following Detailed Description will
be better understood when read in conjunction with the accompanying
figures.
FIG. 1 is flow chart of an exemplar pharmacy filling system that
uses a central fill pharmacy to fill the prescription order and a
local pharmacy to dispense the prescription order to a customer or
patient in accordance with an embodiment of the present invention.
The automated filling machine is filled with medications contained
in bins that have been filled and verified by a pharmacist or
licensed pharmacy technician at a third party location, such as a
wholesaler, a pharmaceutical manufacturer, or a central fill
location.
FIG. 2 is a flow chart of an exemplar pharmacy filling system that
uses a local pharmacy or healthcare facility to fill the
prescription orders by relying on a third party, such as a
wholesaler or pharmaceutical manufacturer, to provide bins filled
with supply medications that have been filed and verified by a
pharmacist or licensed pharmacy technician at the third party
location,
FIG. 3 is a schematic diagram of an exemplar filling of an
individual prescription order of a customer from a stock supply of
the prescribed medication showing the transfer from Unique Drug
Identifier ("UDI") information about the medication in the stock
supply container to a computer readable tag that travels with the
individual prescription order in accordance with an embodiment of
the present invention. In a disclosed embodiment, a computer system
uses the tag to track, monitor and locate the individual
prescription, correlate it with a customer, and maintain UDI
information of the medication contained with the individual
prescription.
FIG. 4 is a schematic diagram of an exemplar "Return to Stock"
comparison whereby the computer system compares the UDI of an
individual prescription order that was not timely dispensed to a
customer or patient to the UDI of a supply container and authorizes
the return of the medication to the stock supply container only if
the UDI's between them are identical.
FIG. 5 is a flow chart of an exemplar prescription order filling
system with a computer system monitored and verified "return to
stock" feature that minimizes medication loss while preserving UDI
integrity of the returned to stock medications.
FIG. 6 is a schematic diagram of an exemplar flow path from a
manufacturer or third party owner of a medication to a
customer/patent that is dispensed to the customer/patient by a
pharmacy that maintains a supply of the medication to dispense to
the customer/patient, but because of the tracking of UDI,
ownership, and pricing tracking by the tracking system, the
pharmacy does not purchase or otherwise obtain ownership of the
medication from the pharmacy. Ownership passes directly from the
manufacturer or third party owner of the medication to the
customer/patient.
FIG. 7 is a schematic diagram of an exemplar pharmacy system having
a dual use storage compartment for securely storing both supply
containers and filled prescription orders with security features to
monitor and track access to items stored therein and monitor
fraudulent dispensing. It also includes security systems such as a
system for globally identifying all medications within the pharmacy
subject to a status change such as a recall or the like, a
real-time inventory module, a fraud module, and a receiver
module.
DETAILED DESCRIPTION
A pharmacy filling system is shown in FIGS. 1-7. A local pharmacy
10 or healthcare facility may use a central fill pharmacy 12 to
assist with filling an individual prescription order 14 as shown in
FIG. 1, or it may fill the prescription order 14 within the local
or retail pharmacy 10 itself as shown in FIG. 2. A prescription
order 14 is usually a lawful written order prescribed to a patient
by a practitioner for the quantity, strength, and dosage
instructions of a given medication or device for the treatment of a
condition of that patient. A prescription order may also be more
broadly defined by a national or local governing authority, and
that definition is also hereby included herein.
FIGS. 3-5 show an exemplar prescription medication dispensing
system 20 to a customer or patent with a computer system 22
monitored and verified "return to stock" feature that minimizes
medication loss while preserving the Unique Drug Identifier ("UDI")
of medication that is returned to stock. FIG. 6 shows an exemplar
use of the dispensing system's UDI, ownership, and pricing tracking
to track the passing of ownership of the dispensed medication
directly from the manufacturer to a customer/patient without a
dispensing pharmacy being financially responsible for the
medication while under its control. Each of these features is
discussed in greater detail below. FIG. 7 shows possible security
features that may be included with the system for ensuring actuate
filling and dispensing of prescription orders, minimizing fraud and
other losses, and maximizing available storage space.
Automated Prescription Filling with System Tracking and
Verification
Regarding FIGS. 1 & 2, in both embodiments, an automated
filling machine or system 30 is used to fill the prescription
orders 14. The automated filling system 30 is located at the
central fill facility 12 in the embodiment of FIG. 1, and at the
local pharmacy 10 or healthcare facility in the embodiment in FIG.
2. At either location, the automated filling system 30 is stocked
with medication supply bins 32 that have been filled and verified
by a pharmacist and/or licensed pharmacy worker 49 at a remote
location 34 such as a wholesaler or the medication manufacturer.
The local pharmacy 10 or healthcare facility is preferably in
electronic or computer communication 40 with the remote location 34
and central fill facility 12, if applicable.
The supply bins 32 are sealed and tagged at the remote location 34,
preferably with an electronic tag 50 such as a barcode, RF tag,
RFID tag, GPS tag, or the like, that travels with each supply bin
32. The tag 50 includes identifying information about the
medication contained within the supply bin 32 to which it is
attached. Preferably, the tag 50 is in communication with a
computer system 22 that includes one or more tag readers 52 that
detect the presence of the tag to determine its location. The
computer system 22 includes a database that may include detailed
information about the medication contained within the supply bin 32
including its location as well as UDI information about the
medication.
More preferably, the tag 50 is a radio-frequency identification tag
("RFID"), and includes Unique Drug Identity ("UDI") information
regarding the medication contained within the bin 32. Such
information can include the lot number, expiration date, drug name,
drug strength, pedigree number, fill date, pharmacist/licensed
pharmacy worker verification and identification, current owner,
pricing, unit cost, and the like for the medication contained in
the bin.
The sealed bins 32 are transported to their respective automated
filling system 30, which is either the central fill pharmacy 12 in
the embodiment of FIG. 1, or the local pharmacy/health care
facility 10 in the embodiment of FIG. 2. A local worker (51, FIG.
7), who may also be tagged with a unique identifier tag 50 so his
or her actions within the pharmacy can also be monitored, tracked
and recorded by the computer system 22, installs the bins 32 into
the automated filling system 30 by breaking the seal. A local
tracking system in communication with the computer system 22, such
as a system disclosed in U.S. Pat. No. 8,479,988 to Louie, et al.
or the like, uses a tag reader 52 or the like to automatically read
the information contained on the tag 50 that is operably secured to
the bin 32. The computer system 22 automatically verifies that the
correct bin 32 has been placed in the correct location within the
automated filling system 30 without requiring a local licensed
pharmacy worker or pharmacists to verify the contents of the bin 32
or its proper location within the automated filling machine 30.
Should the computer system 22 detect a discrepancy, such as the
wrong supply bin 32 being installed in the wrong location, the
system 22 can alert a worker to correct the discrepancy or call of
a licensed pharmacy worker or pharmacist to intervene to correct
the situation.
During filling of the prescription order 14, either at the central
fill pharmacy 12 in FIG. 1 or at the local pharmacy 10 or
healthcare facility of FIG. 2, the supply bins 32 and the
prescription orders 14 are tagged with electronic machine readable
tags 50 that monitor and track their location within the pharmacy
and include information about the prescription orders and/or supply
bin contents (e.g. UDI's) as needed.
The automated filling machine 30 may include standard automated
filling verification systems 60 such as weight verification, label
verification, pill count verification, video comparison of the
pills to an image of the pill in a standard catalog of pills, and
the like. These verification systems 60 verify that the automated
filling machine 30 property placed the correct medication and the
correct amount of that medication into a container that has been
properly labeled for a particular customer or patient. Should these
systems detect a discrepancy, the system alerts a pharmacy worker
of any discrepancies where that particular prescription order 14 is
pulled from the system and manually inspected and corrected by a
pharmacy worker before it is released to a customer or patient.
It can be appreciated, that with the foregoing systems, individual
electronic tagging 50, tracking and monitoring of the supply bins
32 and the prescription orders 14, and automated verifications
systems 60 downstream of the filling machines 30, a filled
prescription order 14 for a refilled prescription may be dispensed
to a customer with only one manual verification of the supply bins
32, by a healthcare worker, well upstream of the individual filling
of the prescription 14. The downstream automated monitoring,
testing, tracking and verification performed by the computer system
22 maintains the integrity of the supply bins 32 and the resulting
filled prescription orders 14.
Of course, the filling system can include additional inspection
stations along the filling path as needed to comply with local
pharmacy dispensing regulations. For example, if a prescription
order 14 is new, and calls for new prescription handling or patient
counseling, a registered pharmacy worker and/or pharmacist 51 can
be called in to verify that particular order and counsel the
customer or patient. Refilled orders can pass this step saving
licensed pharmacy worker's and pharmacist's time.
If desired, the pharmacist or licensed pharmacy worker 49 at a
remote location 34 and/or the pharmacists or licensed pharmacy
worker 51 at the local pharmacy 10 can each wear a tag 50 that is
in communication with the computer system 22. This allows for the
computer system 22 to monitor, track and document which workers
performed which tasks related to both the supply bins 32 and
individual prescription orders 14
System Tracking and Verification of Unique Drug Identifier
Referring to FIGS. 3-5, the computer system 22 can monitor and
track the Unique Identifier such as a Unique Drug Identifier
("UDI") information about the item or items such as medication in
each stock supply container 33 within the system, such as lot
number, manufacturer date, expiration date, drug name, drug
strength, pedigree number, National Drug Code ("NDC"), Drug
Identification Number ("DIN"), cost and pricing information, and
the like. The supply container 33 may be from a previously packaged
bin 32 or a separate container that arrived at the pharmacy by
other methods. As shown in FIG. 3, this UDI information can be
transferred to each individual prescription order 14 when
medication from that supply container 33 is transferred to an
individual prescription order 14.
For example, the supply container can include a first machine
readable tag 50a that is readable by a tag reader 52 in
communication with a computer system 22. A second machine readable
tag 50b can be operably secured to the individual prescription
order 14. The first tag 50a can include UDI information about the
medication contained in the supply container 33 including the
remaining volume or number of pills contained therein. When the
individual prescription order 14 is filled and a portion of the
contents of the supply container 33 are transferred to the
container containing the individual prescription order 14, the
computer system 22 can detect this activity and associate the
individual prescription order 14 of that tagged individual
prescription container to a customer or patent's prescription
order. The computer system can transfer the resulting UDI
information of the supply container 33 to the tag 50b associated
with the individual prescription order 14. This UDI information
from the supply container 33 travels with the individual
prescription order 14 to a storage area 55 until that order is
dispensed to a customer or patient. Preferably, the storage area 55
includes one or more tag readers 52 and transducers 250 in
communication with the computer system 22 that operate as further
described herein.
The stock supply within the stock supply container may also include
one or more items related to a particular patient, or a group of
items related to a particular medical treatment such as first aid
treatment, cardiac treatment, burn treatment, laceration treatment,
anesthesia treatment, and/or a predetermined medical procedure.
UDI Information Preserved when Medication is Returned to Stock
Referring to FIG. 4, should an individual prescription order 14 be
returned to stock or the like, the system can track and store the
UDI information about the returned medication, thereby allowing it
to be re-dispensed without risk of it becoming expired or without
knowing its exact pedigree. The computer system 22 can read the tag
50b associated with the returned prescription order 14 and the tag
50a associated with the supply container 33 and compare the UDI's
of each. If key items of UDI's are identical, such as lot number,
expiration date. NDC and pedigree number, the returned medication
can be placed back into the supply container 33 without
compromising the integrity of the supply container 33 as shown by
arrow 72 in FIG. 4. The system can activate one or more transducers
if the transfer of the returned medication is not authorized and
alert a pharmacy worker if the UDI of the supply container 33 has
been compromised.
Alternatively, if the UDI's between the returned medication and the
supply container 33 do not match, the returned medication can
remain within the storage area for use to fill a new prescription
order as shown by arrow 74 in FIG. 4. The computer system 22 can
alert a pharmacy worker whether to use medication from the returned
prescription order or from the supply container.
Having described how the computer system 22 maintains and tracks
UDI information from the supply containers 33 to the individual
filled prescription orders 14. It can be appreciated that
medication loss can be minimized by preserving UDI integrity of the
returned to stock medications, and inadvertent dispensing of
expired medications to customers and patents can be eliminated.
An exemplar individual prescription filling system 80 taking full
advantage of maintaining medication UDI information integrity
throughout the filling process is shown in FIG. 5. In step 90, a
new individual prescription order is provided to the pharmacy. The
pharmacy first determines if there are qualifying returned to stock
medications available to fill the new prescription order (Step 92).
If there is, the system next determines if there is enough of the
returned to stock medication to fill the new prescription order
(Step 94) and if there is the new prescription order is filled with
from the returned to stock supply (Step 96). In cases where the
supply of returned medication is greater than the amount dispensed
to the new individual prescription order the computer system may
update the volume or quantity of medication in the returned to
stock supply as medication is dispensed to fill the new
prescription order.
Alternatively, if there is none or not a sufficient amount of
returned to stock medication to fill the new prescription order,
the system directs a pharmacy worker or an automated fill system to
fill the new prescription order from the main stock supply
container of the prescribed medication (Step 98).
After the individual filled prescription order is filled either
from an existing returned to stock supply or from the main stock
supply, the computer system transfers the UDI information of the
source supply to the computer readable tag associated with the
individual prescription order (Step 100). More preferably, the
computer system also monitors and tracks the volume or pill count
in both the supply container and the volume or number of pills
placed in the container of the individual prescription. For
example, it consults the database associated with that
customer/patient and determines the number of pills prescribed and
deducts that amount from the selected supply container and adds
them to the filled individual prescription order.
The filled individual prescription order is then stored for
dispensing to a customer or patient (Step 102), and a clock is
initiated to track how long the individual prescription order
remains in the storage area. Preferably, the individual
prescription is stored in an area that is in communication with the
computer system 22 to automatically monitor, detect, and log user
access.
As shown in Step 104, if the individual prescription order is
dispensed to a patient or customer within a predetermined time,
further tracking of the UDI information and location tracking of
the customer's order can stop (step 106). The UDI and other
information can be stored in a database for further reference or
documentation as needed.
Alternatively, if the individual medication is not dispensed to a
patient or customer OR within a predetermined time, the medication
within the individual prescription can be returned to stock (step
112). However, because the UDI information of the supply container
is preserved and transferred to each individual prescription
filled, should a medication contained within a filled prescription
order waiting for pick-up expire before it is picked-up by a
customer or dispensed to a patient (step 110), the system can flag
the discrepancy to a pharmacy worker, such as by activating a
transducer on the tag associated with that prescription order, who
can correct the situation before the customer seeks to pick up the
medication or before it is dispensed to a patient (step 111). The
computer system 22 can further prevent dispensing of an expired
medication to a patient or customer by taking additional security
steps such as calling for a pharmacist override before it will
unlock or locate the prescription order for the pharmacy worker, or
by activating an audible warning alarm or the like.
If desired, the computer system can also update the UDI information
of the individual prescription order 14 and the supply container 33
with a user entered or pharmacy pre-selected configurable date.
Preferably, this configurable date is earlier than the expiration
date of the medication contained in the respective individual
prescription order 14 and supply container 33, and it is selected
to give a patient or customer a reasonable time to use the
medication before it will expire. The previously described flagging
and warning system for expired medications could also be activated
upon reaching this configurable date, thereby preventing the
dispensing of medications that do not have a reasonable time to be
used before they expire.
Also, the electronic tracking of pedigree information of
medications in the supply container also allows the pharmacy to
dispense medications that are closer to their expiration dates
first, and avoid dispensing medications that are too close to their
expiration dates to be meaningfully used by a customer or patient
before they expire. Using the oldest inventory first and avoiding
disposing of expired or nearly expired medications with this system
also saves money for the pharmacy.
The computer system first compares the UDI information of each
individual prescription order with the UDI information of the
supply container for that particular medication (step 114). If the
UDI information is the same, the medication contained within the
individual supply container can be returned to the supply container
(step 116). The pill count or volume of medication in the
individual prescription order returned to the supply container can
be automatically added by the computer system to the UDI
information of the supply container. Alternatively, if the UDI
information between the individual prescription order differs from
the UDI information of the supply container, the returned to stock
medication can be stored and tracked for further use (step 118) as
previously described. Of course, the worker may choose to store
separately even if the UDI's match to save time.
One skilled in the relevant art will recognize that numerous
variations and modifications may be made to the configurations
described above. For example, if desired in step 94, if there is
not a sufficient amount of medication in a returned to stock supply
of medication, a pharmacy may fill only a partial amount of an
individual prescription order from the returned to stock supply. If
it does this, it can pull the remaining supply from the main stock
of the medication supply. If it combines medication from these two
sources of supply medication into one individual container, the UDI
information of that container is compromised. Accordingly, the
computer system will track this individual prescription order to
ensure that it is not returned to stock for reuse. Alternatively,
the pharmacy may provide two individual containers, each with an
individual machine readable tag and each containing the UDI
information of the supply source from which it was filled. In such
case, the medication contained within each individual container may
be returned to stock as previously described while maintaining UDI
integrity of all the medications.
Also, the storage area 55 (FIG. 3) for filled prescription orders
14 needs to be spaced apart from the storage area of the supply
containers. In such case, should a filled individual prescription
order be flagged for being returned to stock and stored in the same
area where the supply of that medication is also stored, the
"return to stock" function can be purely electronic, whereby the
computer system simply reclassifies that that individual
prescription order as being returned to stock medication without
that item actually being moved. Of course, any customer identifying
labeling information would still need to be removed before the
returned item could be dispensed to a new customer.
Ownership of a Customer/Patient's Medication May Transfer from the
Manufacturer or Third Party Owner Directly to the
Customer/Patient.
Referring to FIG. 6, the previously described individual tracking
of UDI, ownership and pricing information a particular customer's
204 prescription order 14 allows ownership of a particular
prescription order 14 to pass directly from the manufacturer or
third party owner 200 of the medication to the customer/patient 204
upon the dispensing of the medication from a pharmacy 202 to the
patent.
The previously discussed "return to stock" feature of the system
allows ownership and pricing information of a particular
prescription order to be preserved when a prescription order has
not been timely picked up by a customer/patient, thereby
maintaining ownership integrity of the prescription order.
Accordingly, it can be appreciated that the pharmacy may maintain a
supply 33 of a medication while the manufacturer or third party
owner 200 of that medication maintains ownership of it until it is
dispensed to a customer/patient. This prevents the pharmacy from
having to purchase and then resell a particular medication that it
stocks. Instead, a manufacturer may supply pharmacies with high
cost medications to dispense without the pharmacy incurring the
financial burden of pre-paying for the supply of medication before
it is ordered or dispensed to a customer/patient. The sale of
individual prescription orders from that supply of medication
triggers the transfer of ownership of that prescription order's
medication to the customer and payment of that medication of the
manufacturer or third party owner of the medication.
In cases where a customer has insurance 300 to pay for a particular
medication, the system can monitor the status of the insurance
transaction between the pharmacy and patent, and temporarily
transfer ownership of a particular medication to the insurer. This
is usually performed when an insurer as paid for a medication on
behalf of a customer, but the customer has not yet fulfilled any
obligations under the insurance agreement such as pay a co-pay to
the pharmacy or the like. In such case, the owner of that
particular medication would be transferred from the manufacturer or
third party owner to the insurance company until the contractual
obligations of the customer have been satisfied and the medication
is dispensed to the customer. The insurer and pharmacy can
establish a protocol for returning ownership back to the
manufacturer or third party owner should the customer fail to pick
up the prescription order within a predetermined period. Thereby,
allowing ownership of the prescription order to transfer back to
the manufacturer or third-party owner without it ever being owned
by the pharmacy.
The foregoing description of embodiments has been provided for
purposes of illustration and description. It is not intended to be
exhaustive or to limit the disclosure. Individual elements or
features of a particular embodiment are generally not limited to
that particular embodiment, but where applicable, are
interchangeable and can be used in a selected embodiment, even if
not specifically shown or described. The same may also be varied in
many ways. Such variations are not to be regarded as a departure
from the disclosure and all such modification are intended to be
included within the scope of the disclosure.
Additional Possible Security Features
Referring to FIG. 7, it can be appreciated that the information
stored in and collected by computer system 22 in communication with
the tags 50 installed on the supply containers 33, individual
filled prescription orders 14 and the workers 150 within the
pharmacy can be used to provide a wide variety of security
features. For example, it can be used to ensure the proper
dispensing of medications, minimize required storage space, quickly
identify status changed medications within the system, and identify
fraudulent, excessive or otherwise improper dispensing of
medications. Examples of these types of security measures are
provided below.
Fraud Module
The computer system 22 can be equipped with a fraud module 302,
which may be software provided in the system, that evaluates the
collected UDI data associated with filling a prescription order 14
and alerts one or more key employees with an alerting system if a
predetermined discrepancy is detected. For example, because the
collected data includes and stores the identity of each worker 51,
352, 354 who has had access to a particular supply container 33 of
a medication, it can monitor how much of a particular medication is
being dispensed by each worker within the pharmacy. If a particular
worker dispenses an unusually large amount of a particular
medication, the fraud module 302 can activate the alerting system
308 to alert the management or other key employees of the
discrepancy.
If desired, the system can "lock out" that employee from gaining
future access to that supply of medication or even all medications
until the discrepancy is cleared by the key employee or
management.
The predetermined criteria for the fraud module to activate the
alerting system can be preset amounts of a particular medication
dispensed within a certain amount of time by one worker or by all
workers within the pharmacy. The preset amounts can be manually
entered by the key employee or management through an input device
304 in communication with the system.
In addition and/or alternatively, the system 22 can monitor the
dispensing rates of medications over a predetermined timeframe to
establish historical consumption data and activate the alerting
system 308 when the dispensing of a particular medication exceeds
this historical data by a predetermined amount. For example, if the
system determines that the pharmacy usually dispenses 100 units of
a particular medication per day, it can activate the alerting
system if it detects that 125 or more units have been dispensed in
a day. This tracking can be covert, in that the pharmacy workers
dispensing the medications do not know they are being monitored for
this activity, or overt, where the workers know this tracking
exists thereby deterring them from engaging in these types of
improper dispensing activities.
The activating of this system doesn't necessarily mean a medication
has been improperly dispensed or a particular worker has committed
fraud. The system just alerts management of this discrepancy in
real-time to allow management the opportunity to investigate the
issue and correct it or override the alert as needed.
Medication Status Change Detection
A status change module 310 in communication with the computer
system may also be provided. On occasion, the dispensing status of
a medication may change. For example, a particular supply of
medication from the manufacturer may be found contaminated or
otherwise unsuitable for dispensing. In such case, the manufacturer
will issue a recall notice to pharmacies. That notice will
typically be limited to a medications with a specific UDI lot
number or the like.
Because the present pharmacy tracking system monitors and tracks
specific UDI information of medications all the way through to the
individual filled prescription orders, the status change module 310
can automatically detect and identify any medications subject to a
recall or the like. For example, if a particular lot number of a
particular medication is recalled, the status change module can
enter that lot number and medication name into the system to
activate transducers 250 associated with all affected medications
within the system.
This includes both affected medications still within supply
containers 33 and those already dispensed and awaiting pick-up as
filled prescription orders 14. Accordingly, should the pharmacy
fail to promptly remove an affected medication, the system can
alert or prevent a worker from dispensing a particular affected
medication. Also, the UDI expiration of the supply of medication
can be automatically monitored by the system. If a medication
becomes expired while stored in the system, the system can
automatically identify that supply of medication for removal from
the system and prevent its dispensing to customers or patients.
The status change module 310 can receive notice of medications
subject to a status change from a variety of sources. A worker 51
can manually enter medication and lot numbers into the system
through the input/output device 304 in communication with the
system. Alternatively or in addition, the status change module can
be in continuous communication with an auxiliary source such as a
national medication recall database or databases provided by the
medication manufacturers thereby providing real-time notice and
response to quickly prevent dispensing of affected medications.
In addition, the alerting system 308 can include customer or
patient contact information such as their phone numbers, email
addresses and/or their mailing addresses. In cases where the
computer system 22 detects that an affected medication has already
been dispensed to a customer or patient, the alerting system can be
activated to notify that customer or patient as soon as possible by
common means such as sending an email, text message or causing a
pharmacy worker to call the customer or patient with this
information.
Dual Use Storage Area
In order to maximize available storage space, the storage area 55
may be a storage compartment or cabinet 57 that is adapted to hold
both supply containers 33 and filled prescription orders 14 within
it, but without compromising security or providing unauthorized
access of either product. As best shown in FIG. 7, the cabinet 57
can have limited access and a security system that limits that
access. For example, the storage area in the compartment can be
inside a lockable drawer 202. A plurality of independently operably
lockable drawers may be provided in the same frame. The lock for
that drawer is in communication with the computer system 22, and
opened by the computer system only when it detects and verifies the
identity of a particular worker who is seeking access to a supply
container or filled prescription order received therein.
The compartment includes one or more tag readers 52 that
automatically detect the presence of tags 50 on both supply
containers 33 and filled prescription orders 14 within the system.
It can activate transducers 250 on both the exterior of the cabinet
drawer and on the shelf adjacent to the supply container 33 or
filled prescription order 14. Thereby alerting a particular worker
354 to the exact location where the desired supply container 33 or
filled prescription order 14 is located.
Moreover, the system 22 can detect the removal of a supply
container or filled prescription order from the compartment and
compare the removed item against the desired item being sought by
the worker 354. Should a worker inadvertently select the wrong item
from the cabinet, the alerting system 308 will alert the worker 354
and management 352 of the discrepancy. Accordingly, pharmacy
workers filling prescription orders from supply containers 333 and
those dispensing filled prescription orders 14 to customers and
patients may use the same storage compartment 57 while maintaining
control of items received therein.
Preferably, the identity of each worker 51, 354 accessing the
compartment is determined from a tag 50 worn or held by the worker.
That tag is preferably an RFID tag, but alternative machine
readable tags could be used including bar codes or the like.
Alternative forms of identification of the worker can be used too.
For example, keypad entry and/or biometric data such as fingerprint
detectors and/or retinal eye scanners and the like could be
used.
It can be appreciated that the preferred system 22 monitors and
tracks the real-time location of supply containers and filled
prescription orders by tag readers detecting the physical location
of these items at predetermined locations within the pharmacy.
Accordingly, the computer system updates its database with this
information in response to the worker's choice as to where to put a
particular item rather than the system first telling a worker where
to put an item and assuming that worker has actually complied with
that instruction. This allows supply containers 33 and filled
prescription orders 14 to be placed anywhere within the pharmacy
and in the storage compartment and still be easily located as
needed.
Receive Module
This real-time updating of the compiled database of UDI, worker
access identification, physical location of the item, customer
identification and the like can be used to provide a wide variety
of other benefits. For example, a real-time manifest of current
medications with the pharmacy can be provided. A receive module 306
may be provided to the system 22 that allows a supply shipment
received by the pharmacy to be instantly compared to a manifest to
determine if any discrepancies exist. In one embodiment, the
contents of a supply shipment may include numerous supply
containers of different medications. At the pharmacy, each supply
container within the shipment may be assigned an individual tag and
the UDI information, including quantity, associated with the
medication contained in the respective supply container is
associated with the tag 50. The receive module 306 can compare the
original manifest of the supply shipment with the individual tags
associated with each individual supply container and note any
discrepancies between the manifest and the tagged individual supply
containers. This minimizes risk of items received within a bulk
supply shipment from inadvertently or intentionally failing to be
entered into the system by a worker upon receipt at the pharmacy.
If the received quantity matches the manifest quantity for that
freight order then the system can automatically "increment" the
real-time inventory of the system.
Real-Time Inventory Module
Similarly, a real-time inventory module 312 may be provided that
uses the collected data and tracking of the system allow for the
system 22 to provide a real-time inventory of available supply
containers and their medications stored therein. The inventory
module 312 may include an input-output device 304 that allows
pharmacy workers to request inventory information, and/or
predetermined minimums may be entered into the system to alert the
pharmacy workers should a particular medication fall below a
predetermined minimum amount. If desired, the system can be
provided to automatically re-order supplies that fall below these
predetermined limits. Alternatively or in addition, a real-time and
accurate report can be generated and logged to comply with physical
count requirements of national, state and/or local authorities and
laws.
Perpetual Log/Blind Back Count
The collected data and tracking system may also be used to create
and maintain a perpetual data log of key transactions and
processes. For example, in one embodiment when a pharmacy worker
may decide to fill a prescription order, he or she can scan a
prescription barcode on the label attached to the prescription
order. The computer system knows the UDI's, such as National Drug
Code (NDC), and the quantity of the desired medication to be filled
with that prescription order.
The computer system 22 can compare the prescription order's NDC to
what is available in supply containers in the cabinet, and if there
is an exact match, it can direct them to one or more supply
containers with that NDC and to enough quantity as more than one
supply container may be needed. Preferably, the system would direct
the worker to the oldest matching NDC first plus any returned to
stock product with matching UDI's.
In one embodiment, the system 22 can alert the worker 354 by
activating transducers 250 such as lights positioned on the
exterior and interior portions of the cabinet adjacent to the
desired supply container(s). The lights on the cabinet drawer
lights up where the desired supply containers are located. When the
worker identifies themselves to the computer system at the
identified drawer, the lock will unlock and the known user can
access/open the drawer. Then, the cell or cells lights up with the
desired supply containers. This way the system can electronically
verify that the correct UDI is picked. The system logs accuracy and
accountability. Once the worker retrieves the basket with the
supply container and closes the drawer the supply container is
"checked out" to that worker.
Since the system knows what prescription order this transaction was
for, and the system also knows the quantity of the medication to
the removed from the supply container to fill that prescription
order, the system automatically, decrements and stores in memory
that number from collected data of the supply container used to the
fill the prescription order. Accordingly, the system uses this
information to maintain a current log of the quantity of medication
remaining in the supply container used to fill the prescription
order.
If desired, the system 22 can require the worker 51 to manually
count the remaining medication in the supply container used to fill
the prescription order and manually enter that quantity into the
system though a user interface. If the quantity manually entered by
the worker matches the system's self-maintained current log of
quantity of medication remaining in that supply container then the
system will authorize that worker to return that supply container
to the cabinet. This process is referred to as a "blind back
count." Upon the system authorizing the return of the supply
container, the system can unlock the cabinet upon determining the
identity of the worker seeking entry and remove the "check-out" of
that supply container to the worker, and verify that the supply
container has indeed been returned to the cabinet.
If the system 22 determines there is a discrepancy, the worker must
have a pharmacist or other authorized management personnel with
higher authority adjust the inventory in the system so that the
manual count matches the system's count, and the user can then put
the supply container back into the cabinet as previously described.
The system can therefore identify which workers are historically
requiring an inventory adjustment and thereby prevent and/or
monitor for fraudulent transactions by those workers.
In this case, the worker 51 who had the supply container
"checked-out.", the manager 352 who adjusted the inventory and any
workers 354 who accessed (put away) the supply container 33
previously to this transaction is logged and an exception is
created that must be reviewed by the manager 352. The manager's
review is also logged.
Also, since the system 22 knows there was a prescription order 14
filled with this transaction, the system 22 can also look to see if
a tag 50 associated with the filled prescription order 14 is linked
(coupled) to the transaction and alert a worker 362 if the filled
prescription order is not promptly located and accounted for by the
system. The filled prescription order 14 may be returned to the
same cabinet as the supply container 33 thereby maximizing
available storage space within the pharmacy.
Also, the system can mandate that this linked prescription order be
checked by an additional worker such as a pharmacist before it goes
into the cabinet. The system does this by requiring a "double
count" where the additional worker double counts what is in the
filled prescription order's vial, enters this into the system and
if it matches, is authorized to put this filled prescription order
into the cabinet(s) for customer pick up later. Should another
(non-pharmacist or user without privilege) put this basket into the
cabinet, the system will generate an error and alert the pharmacy
workers.
Also, if desired the system 22 can have a sense of "roles" within
the pharmacy. It can be equipped to provide increasing access
privileges to the cabinet based on the roll assigned to each
worker. For example, a technician 51 may be allowed to access
supply containers 33, including stock storage containers and the
like, but a clerk 354 may only be able to access a filled
prescription order 14. Because the system monitors and tracks the
identify of each worker gaining access to the cabinet, and can
differentiated between supply containers 33 and filled prescription
orders 14 within it, it can be provided with predetermined rules to
limit access to particular items within the system.
Preferably, to maintain the chain of custody, the system would
verify that the person doing the last count (double count) be the
same person to put away into our cabinet. If not, the system can
generate an error and alert the pharmacy workers.
Also, the last worker to have touched a particular supply
container, bulk shipment or filled prescription order can be
determined, and the amount of time it takes a particular pharmacy
worker to perform a particular task can be determined. The data
contained in this database can be stored indefinitely for future
reference and analysis as needed, thereby improving
accountability.
One skilled in the relevant art will recognize that numerous
variations and modifications may be made to the configurations
described above. For example, not all of the security features
noted herein need be included in a commercial embodiment. Such
modifications and additional embodiments can be made without
departing from the scope of the present invention, as defined by
the appended claims.
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